CLASS III Drug recall · Reported 24 Apr 2013 · FDA Enforcement Report
Suprax (cefixime for oral suspension) USP, 100 mg/ bottles recalled
Lupin Pharmaceuticals is recalling Suprax (cefixime for oral suspension) USP, 100 mg/ bottles (when reconstituted), distributed nationwide in the US. The recall was initiated on 31 Jan 2013 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-264-2013
- FDA event ID
- 64325
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 31 Jan 2013
- FDA classified
- 18 Apr 2013
- Reported
- 24 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 31 Jan 2013 | Recall initiated by company | |
| 18 Apr 2013 | Classified by FDA | +77 days |
| 24 Apr 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Discoloration; Product may not meet specifications for color description once reconstituted.
Product as listed by the FDA
Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted), Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 68180-202-03.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Discoloration; Product may not meet specifications for color description once reconstituted.
Which lots are affected?
Lot #s: MSA 2021A, MSA 2024A, MSA 2025A, Exp July 2014
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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